Nausea and Vomiting in Pregnancy (NVP)TN-NVPNCT06566274
Thumbtack Needle in the Treatment of NVP
A study testing thumbtack needle in people with Nausea and Vomiting in Pregnancy (NVP), run by Dongmei Huang at 13 sites in China.
Trial summary
This project intends to use multi-center, large-sample, randomized, controlled, blinded clinical trials to observe the clinical efficacy and safety of thumbtack needle (TN) on nausea and vomiting in pregnancy (NVP). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Nausea and Vomiting in Pregnancy (NVP)
- What is being tested?
- thumbtack needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 13 sitesChina
- Study dates
- 1 Oct 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The mother\'s age is 20 ~ 45 years old, the gestational age is 6 ~ 12 weeks, and the ultrasound confirms that it is an intrauterine single or multiple pregnancy, and the weight loss is less than 10% compared with before pregnancy.
- Women diagnosed with moderate to severe NVP in the first trimester: the severity of NVP was determined by the PUQE score (see Table 1), and the PUQE score ranged from 3 ~ 15, < 6 was mild NVP, 6 ~ 12 was moderate NVP, and ≥13 was severe NVP. PUQE score ≥ 6 may be included in this study.
- Women voluntarily sign the informed consent form.
Who cannot join
- Age >20 years, and <45 years.
- Gestational > 6 weeks, or <12 weeks.
- PUQE score <6.
- frequent nausea and vomiting, weight loss of >10% compared with before pregnancy; or symptoms such as listlessness, paleness, dry skin, sunken eye sockets, and a marked decrease in urine output (less than 400ml of urine in 24 hours or less than 5 times and a small amount of urine in 24 hours).
- At rest, body temperature > 38°C, systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 60 mmHg or > 90 mmHg, heart rate ≥ 100 beats per minute, or oxygen saturation < 95%.
- Urinalysis: urine ketones: +++ and above; or (and) urine protein: ++ and above.
Show all 15Show fewer
- Blood biochemistry: serum potassium≤3.0mmol/L, serum sodium≤130mmol/L; or abnormal liver function: elevated liver enzymes ≥ 2 times the upper limit of normal; or renal dysfunction: elevated serum creatinine and urea nitrogen.
- Other digestive diseases that cause nausea and vomiting, such as gastrointestinal infections (with diarrhea), gastric ulcers (with epigastric pain or hematemesis), cholecystitis, biliary roundworms, pancreatitis (with abdominal pain, plasma amylase levels rise to 5 ~ 10 times normal), viral hepatitis (positive hepatitis virology, liver enzyme levels ≥ 1 000 U/L) or acute fatty liver during pregnancy, tumors of the digestive tract.
- Suffering from immune diseases such as systemic lupus erythematosus, scleroderma, dermatomyositis, IgG4-related diseases, immune nephropathy, etc.
- Have uncorrected diseases of the endocrine system, such as diabetes, Addison's disease, hyperthyroidism, hypothyroidism, thyroid tumors, adrenal tumors, etc.
- Suffering from neurological diseases such as migraine, neuromyelitis optica, epilepsy, neurologic tumors, etc.
- In the past 1 week, have taken antiemetic drugs such as ondansetron, metoclopramide (metoclopramide), promethazine, anti-vomiting Chinese medicine, etc.
- Monoamine oxidase inhibitors are used.
- Have received TN treatment in recent 3 months.
- Unwilling to sign the informed consent of this study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Aksu Prefecture Maternal and Child Health Hospital
Aksu, Xinjiang, 843099
Dr. Fan, 86-18935844102, fll8301@163.com
- Recruiting
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, 434300
Dr. Xu, 86 18972363268, 110810237@qq.com
- Recruiting
Dongchangfu District Maternal and Child Health Care Hospital of Liaocheng City
Liaocheng, Shandong, 252004
Dr. Xi, 86-15206356510, 358179987@qq.com
- Recruiting
Nanzhang County Traditional Chinese Medicine Hospital
Nanzhang Chengguanzhen, Hubei, 441500
Dr. Zhang, 86-13871606542, 3325322588@qq.com
- Recruiting
Qianjiang Central Hospital
Qianjiang, Hubei, 433100
Dr. She, 86 15871905339, 471699755@qq.com
- Recruiting
Qianjiang Maternal and Child Health Care Hospital
Qianjiang, Hubei, 433199
Dr. Yuan, 86 13597428085, 2961656031@qq.com
- Recruiting
Shiyan People's Hospital
Shiyan, Hubei, 442099
Dr. Zhang, 86 18671988831, 337349125@qq.com
- Recruiting
Suizhou Maternal and Child Health Care Hospital
Suizhou, Hubei, 441399
Dr. Bao, 86-18607225753, 592992868@qq.com
- Recruiting
Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine
Wuhan, Hubei, 430014
Dr. Liu, 86 13343452501, 3788786252@qq.com
- Recruiting
Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Dr. Huang, 86 027-83663275, hdmjcr@qq.com
- Recruiting
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, 441001
Dr. Yang, 86 15335897469, 1979422122@qq.com
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441106
Dr. Zhao, 86-15172682096, 916669206@qq.com
- Recruiting
Xiaogan Maternal and Child Health Care Hospital
Xiaogan, Hubei, 432001
Dr. Nie, 86 13669020358, 7725553@qq.com
About this study
Official title: Clinical Efficacy and Safety Evaluation of Thumbtack Needle in Nausea and Vomiting in Pregnancy: a Randomized Controlled Clinical Trial
This project intends to use multi-center, large-sample, randomized, controlled, blinded clinical trials to observe the clinical efficacy and safety of thumbtack needle (TN) on nausea and vomiting in pregnancy (NVP).
Read the detailed description
Nausea and vomiting in pregnancy (NVP) is the most common and intractable problem in the first trimester and is the second most common presentation during pregnancy. All types of NVP affect the quality of life of pregnant women, and the intensity of influence increases with the frequency of symptoms. Due to the lack of awareness of NVP and the concern about the teratogenicity of drugs to embryos, the treatment of NVP is always insufficient, and the choice of drug regimen is conservative.
Acupuncture using traditional millineedle is effective on NVP, however, it is generally painful when the millineedle is inserted into the body, and the needling sensation of soreness, numbness, swelling and pain during acupuncture is sometimes beyond patient's acceptability, or even produce adverse effects on pregnancy. Moreover, patients may have to visit acupuncturist daily using millineedle, which may causes high financial costs and reduce the medial adherence. Therefore, although acupuncture with millineedle is effective on NVP, its application in clinical practice is still very limited.
As a kind of intradermal needle, thumbtack needle (TN) is a method of shallow puncture and long-term retention needle. Although the amount of stimulation of TN is weaker than that of millineedle, it has a much longer effect and can produce continuous and stable stimulation, and therefore, its cumulative effect is often better than that of traditional millineedle acupuncture. Moreover, due to the tiny needle body of TN (the diameter of the needle body is only 0.15 ~ 0.25mm, and the length of the needle body is only 1.2 ~ 2.5mm), it will not hurt the subcutaneous nerves, blood vessels, viscera and other tissues, which is very comfortable and safe to treat, and overcomes the needle sting pain of traditional millineedles. However, up to now, it is unknown whether TN can produce the same effect as the acupuncture in NVP.
This project is a multi-center, large-sample and blinded RCT designed to collect the highest quality evidence of complete data, including nausea and vomiting, quality of life, anxiety and depression, weight change, blood electrolyte levels, liver and kidney function, thyroid function, intravenous fluid treatment, use of additional drugs, hospital admission, pregnancy complications (gestational diabetes and hypertensive diseases), pregnancy outcomes and neonatal outcomes in women with VNP.
- Conditions
- Nausea and Vomiting in Pregnancy (NVP)
- Being tested
- thumbtack needle, sham thumbtack needle
- Keywords
- Nausea and vomiting in pregnancy, Thumbtack needle
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thumbtack needleDevice
As a kind of intradermal needle, thumbtack needle (TN) is a method of shallow puncture and long-term needle.After the TN is attached into the acupoints, it will be reserved in the acupoints for 3 days. After 3 days of retention of TN, the patient is instructed to go to the hospital, where the doctor removes the needle, disinfect the local skin of acupoints and conducts the next TN treatment. A total of 5 treatments were applied for a duration of 15 days.
sham thumbtack needleDevice
The sham TN used in the sham TN group has no needle body and its appearance and shape are similar to the real TN. But it does not produce a needle-like effect.
The acupoints of sham TN group are the same as those of TN group. The use of sham TN is the same as that of the TN group. After 3 days retention of sham TN, the patient will be instructed to go to the hospital, where the doctor remove the sham TN, and conduct the next treatment after local skin disinfection. A total of 5 treatments will be applied for a duration of 15 days.
| Study group | Role | What they receive |
|---|---|---|
| thumbtack needle (TN) group | Active comparator | The main acupoints of treatment are Zhongwan (CV12), bilateral Neiguan (SP6), and bilateral Zusanli (ST36), with a total of 5 acupoints. patients with Qi stagnation should be added Danzhong (CV17) or Ashi acupoint (the most prominent tender point between CV 17 and CV12), patients with liver and stomach disharmony should be added bilateral BL17, patients with phlegm-dampness obstruction should be added bilateral ST40, and patients with weak spleen and stomach should be added bilateral BL21. The above acupoints are treated with TN. The TN will be reserved in the acupoints for 3 days. During the 3-day retention of TN, the patient presses the TN 3 times a day and half a minute per time per acupoint. After 3 days of retention of TN, the patient is instructed to go to the hospital and receive the next TN treatment. A total of 5 treatments were applied for a duration of 15 days. Receives: Device: thumbtack needle |
| sham TN group | Sham comparator | The acupoints of sham TN group are the same as those of TN group. The use of sham TN was the same as that of the TN group. During the 3-day retention of sham TN, the patients are asked not to press them. After 3 days retention of sham TN, the patient was instructed to go to the hospital, where the doctor removed the sham TN, and conducted the next treatment after local skin disinfection. A total of 5 treatments were given for a duration of 15 days. Receives: Device: sham thumbtack needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15.
PUQE scores ranged 3 to 15, with higher scores indicating a worse outcome. PUQE scores were evaluated before treatment and on days 3, 6, 9, 12, and 15 of treatment. The primary outcome measure was the change of PUQE score from baseline to day 15.
Measured: Baseline to day 15
Secondary outcomes (44)
The Nausea and Vomiting of Pregnancy Quality of Life (NVPQOL) questionnaire
The NVPQOL range 30-210, with higher scores means a worse quality of life
Measured: Baseline to day 15
Anxiety status survey: Zung-SAS
Zung-SAS range 25-100, with higher scores means more severe anxiety
Measured: Baseline to day 15
Depression status survey: Zung-SDS
Zung-SDS range 20-80, with higher scores means more severe depression
Measured: Baseline to day 15
Sleep status survey: The Pittsburgh sleep quality index (PSQI)
PSQI range 0-21, with higher scores means poorer sleep status
Measured: Baseline to day 15
Change of maternal weight from baseline to last visit
Change of maternal weight from baseline to the last visit
Measured: Baseline to day 15
Change of electrolyte index (sodium)
Value changes from baseline to the last visit. Unit: mmol/L
Measured: Baseline to day 15
Change of electrolyte index (potassium)
Value changes from baseline to the last visit. Unit: mmol/L
Measured: Baseline to day 15
Change of electrolyte index (calcium)
Value changes from baseline to the last visit. Unit: mmol/L
Measured: Baseline to day 15
Change of electrolyte index (chlorine)
Value changes from baseline to the last visit. Unit: mmol/L
Measured: Baseline to day 15
Change of electrolyte index (phosphorus)
Value changes from baseline to the last visit. Unit: mmol/L
Measured: Baseline to day 15
Change of electrolyte index (magnesium)
Value changes from baseline to the last visit. Unit: mmol/L
Measured: Baseline to day 15
Change of electrolyte index (iron)
Value changes from baseline to the last visit. Unit: μmol/L
Measured: Baseline to day 15
Change of electrolyte index (zinc)
Value changes from baseline to the last visit. Unit: μmol/L
Measured: Baseline to day 15
Carbon dioxide combining power in the blood
carbon dioxide conbining power in the artery blood. Unit: mmol/L
Measured: Baseline to day 15
Change of AST
Value changes from baseline to the last visit. Unit: U/L
Measured: Baseline to day 15
Change of ALT
Value changes from baseline to the last visit. Unit: U/L
Measured: Baseline to day 15
Change of ALP
Value changes from baseline to the last visit. Unit: U/L
Measured: Baseline to day 15
Change of creatinine
Value changes from baseline to the last visit. Unit: μmol/L
Measured: Baseline to day 15
Change of urea
Value changes from baseline to the last visit. Unit: mmol/L
Measured: Baseline to day 15
Change of TSH
Value changes from baseline to the last visit. Unit: mIU/L
Measured: Baseline to day 15
Change of free triiodothyronine
Value changes from baseline to last visit. Unit: pmol/L
Measured: Baseline to day 15
Change of free thyroxine
Value changes from baseline to the last visit. Unit: pmol/L
Measured: Baseline to day 15
Change of cortisol
Value changes from baseline to the last visit. Unit: ug/dL
Measured: Baseline to day 15
Change of ghrelin
Value changes from baseline to the last visit. Unit: ng/ml
Measured: Baseline to day 15
Change of leptin
Value changes from baseline to the last visit. Unit: ng/ml
Measured: Baseline to day 15
Change of 5-hydroxytryptamine
Value changes from baseline to the last visit. Unit: ng/ml
Measured: Baseline to day 15
Change of substance P
Value changes from baseline to the last visit. Unit: pg/ml
Measured: Baseline to day 15
Change of arginine vasopressin plasma
Value changes from baseline to the last visit. Unit: pg/ml
Measured: Baseline to day 15
Change of GDF 15
Value changes from baseline to the last visit. Unit: pg/ml
Measured: Baseline to day 15
Change of IGFBP 7
Value changes from baseline to the last visit. Unit: ng/ml
Measured: Baseline to day 15
Number of participants with intravenous fluid treatment during treatment
If the patient suffers from dehydration or electrolyte imbalances, intravenous fluid treatment will be done.
Measured: Baseline to day 15
Number of participants with concomitant treatment
How many participants with concomitant treatment
Measured: Baseline to day 15
Number of participants with hospital admission during treatment
If the patient suffers from further aggravation of neasua and vomiting or hyperemesis gravidarum, hospital admission will be done.
Measured: Baseline to day 15
Number of participants with termination of pregnancy
If the patient suffers from further aggravation of hyperemesis gravidarum, the termination of a wanted pregnancy will be done due to life in danger. Or if congenital anomalies are found by ultrasound, the termination of a wanted pregnancy will be done.
Measured: Data collected from baseline to 1 week after termination of pregnancy
Pregnancy complications
Pregnancy complications including miscarriage (in the first trimester and in the second trimester), hypertensive disorders, gestational diabetes and so on.
Measured: Data collected from baseline up to 42 days after parturition
Number of participants with preterm birth
How many participants with preterm birth
Measured: Data collected from baseline to 42 days after postpartum
Delivery outcomes
Delivery outcomes including live birth, vaginal birth, caesarean section, gestational age, etc.
Measured: Data collected from baseline to 42 days after postpartum
Number of participants with neonatal congenital anomalies
Participants with neonatal congenital anomalies
Measured: Data collected from baseline to 42 days after postpartum.
Number of participants with neonatal mortality
Participants with neonatal mortality
Measured: Data collected from baseline to 42 days after postpartum.
Number of participants with neonatal hypoglycemia
Participants with neonatal hypoglycemia.
Measured: From baseline to 42 days after postpartum.
Number of participants with neonatal NICU admission.
Participants with neonatal NICU admission.
Measured: From baseline to 42 days after postpartum.
Patient's satisfaction with treatment
Questionnaire such as loss of confidence, doubt of the efficacy or intolerance to the treatment of TTN and so on. The answer is "yes" or "no".
Measured: Baseline to day 15
Patient's compliance with treatment
The percentage of the participants which finish the treatment and the follow-up.
Measured: Baseline to 42 days after postpartum.
Adverse events and serious adverse events
The percentage of adverse events and serious adverse events
Measured: Baseline to the end of follow-up (four weeks after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting in Pregnancy (NVP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongmei Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongmei Huang, Huazhong University of Science and Technology
- Investigators
- Dongmei Huang, Doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566274
- Sponsor's protocol ID
- TN-NVP
- Acronym
- TN-NVP
- Status last verified
- Jan 2026
- First submitted
- 12 Aug 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety Evaluation of Thumbtack Needle in Nausea and Vomiting in Pregnancy: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06566274
- Acronym / sponsor ID
- TN-NVP / TN-NVP
- Conditions
- Nausea and Vomiting in Pregnancy (NVP)
- Keywords
- Nausea and vomiting in pregnancy, Thumbtack needle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Dongmei HuangUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project intends to use multi-center, large-sample, randomized, controlled, blinded clinical trials to observe the clinical efficacy and safety of thumbtack needle (TN) on nausea and vomiting in pregnancy (NVP).
Detailed description
Nausea and vomiting in pregnancy (NVP) is the most common and intractable problem in the first trimester and is the second most common presentation during pregnancy. All types of NVP affect the quality of life of pregnant women, and the intensity of influence increases with the frequency of symptoms. Due to the lack of awareness of NVP and the concern about the teratogenicity of drugs to embryos, the treatment of NVP is always insufficient, and the choice of drug regimen is conservative.
Acupuncture using traditional millineedle is effective on NVP, however, it is generally painful when the millineedle is inserted into the body, and the needling sensation of soreness, numbness, swelling and pain during acupuncture is sometimes beyond patient's acceptability, or even produce adverse effects on pregnancy. Moreover, patients may have to visit acupuncturist daily using millineedle, which may causes high financial costs and reduce the medial adherence. Therefore, although acupuncture with millineedle is effective on NVP, its application in clinical practice is still very limited.
As a kind of intradermal needle, thumbtack needle (TN) is a method of shallow puncture and long-term retention needle. Although the amount of stimulation of TN is weaker than that of millineedle, it has a much longer effect and can produce continuous and stable stimulation, and therefore, its cumulative effect is often better than that of traditional millineedle acupuncture. Moreover, due to the tiny needle body of TN (the diameter of the needle body is only 0.15 ~ 0.25mm, and the length of the needle body is only 1.2 ~ 2.5mm), it will not hurt the subcutaneous nerves, blood vessels, viscera and other tissues, which is very comfortable and safe to treat, and overcomes the needle sting pain of traditional millineedles. However, up to now, it is unknown whether TN can produce the same effect as the acupuncture in NVP.
This project is a multi-center, large-sample and blinded RCT designed to collect the highest quality evidence of complete data, including nausea and vomiting, quality of life, anxiety and depression, weight change, blood electrolyte levels, liver and kidney function, thyroid function, intravenous fluid treatment, use of additional drugs, hospital admission, pregnancy complications (gestational diabetes and hypertensive diseases), pregnancy outcomes and neonatal outcomes in women with VNP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thumbtack needle (TN) group | Active comparator | Device: thumbtack needleThe main acupoints of treatment are Zhongwan (CV12), bilateral Neiguan (SP6), and bilateral Zusanli (ST36), with a total of 5 acupoints. patients with Qi stagnation should be added Danzhong (CV17) or Ashi acupoint (the most prominent tender point between CV 17 and CV12), patients with liver and stomach disharmony should be added bilateral BL17, patients with phlegm-dampness obstruction should be added bilateral ST40, and patients with weak spleen and stomach should be added bilateral BL21. The above acupoints are treated with TN. The TN will be reserved in the acupoints for 3 days. During the 3-day retention of TN, the patient presses the TN 3 times a day and half a minute per time per acupoint. After 3 days of retention of TN, the patient is instructed to go to the hospital and receive the next TN treatment. A total of 5 treatments were applied for a duration of 15 days. |
| sham TN group | Sham comparator | Device: sham thumbtack needleThe acupoints of sham TN group are the same as those of TN group. The use of sham TN was the same as that of the TN group. During the 3-day retention of sham TN, the patients are asked not to press them. After 3 days retention of sham TN, the patient was instructed to go to the hospital, where the doctor removed the sham TN, and conducted the next treatment after local skin disinfection. A total of 5 treatments were given for a duration of 15 days. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The mother\'s age is 20 ~ 45 years old, the gestational age is 6 ~ 12 weeks, and the ultrasound confirms that it is an intrauterine single or multiple pregnancy, and the weight loss is less than 10% compared with before pregnancy.
- Women diagnosed with moderate to severe NVP in the first trimester: the severity of NVP was determined by the PUQE score (see Table 1), and the PUQE score ranged from 3 ~ 15, < 6 was mild NVP, 6 ~ 12 was moderate NVP, and ≥13 was severe NVP. PUQE score ≥ 6 may be included in this study.
- Women voluntarily sign the informed consent form.
Key exclusion criteria (15 listed)
- Age >20 years, and <45 years.
- Gestational > 6 weeks, or <12 weeks.
- PUQE score <6.
- frequent nausea and vomiting, weight loss of >10% compared with before pregnancy; or symptoms such as listlessness, paleness, dry skin, sunken eye sockets, and a marked decrease in urine output (less than 400ml of urine in 24 hours or less than 5 times and a small amount of urine in 24 hours).
- At rest, body temperature > 38°C, systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 60 mmHg or > 90 mmHg, heart rate ≥ 100 beats per minute, or oxygen saturation < 95%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thumbtack needleAs a kind of intradermal needle, thumbtack needle (TN) is a method of shallow puncture and long-term needle.After the TN is attached into the acupoints, it will be reserved in the acupoints for 3 days. After 3 days of retention of TN, the patient is instructed to go to the hospital, where the doctor removes the needle, disinfect the local skin of acupoints and conducts the next TN treatment. A total of 5 treatments were applied for a duration of 15 days. | Device | thumbtack needle (TN) group |
| sham thumbtack needleThe sham TN used in the sham TN group has no needle body and its appearance and shape are similar to the real TN. But it does not produce a needle-like effect. The acupoints of sham TN group are the same as those of TN group. The use of sham TN is the same as that of the TN group. After 3 days retention of sham TN, the patient will be instructed to go to the hospital, where the doctor remove the sham TN, and conduct the next treatment after local skin disinfection. A total of 5 treatments will be applied for a duration of 15 days. | Device | sham TN group |
Primary outcome
Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15.
Time frame: Baseline to day 15
PUQE scores ranged 3 to 15, with higher scores indicating a worse outcome. PUQE scores were evaluated before treatment and on days 3, 6, 9, 12, and 15 of treatment. The primary outcome measure was the change of PUQE score from baseline to day 15.
44 secondary outcomes
The Nausea and Vomiting of Pregnancy Quality of Life (NVPQOL) questionnaire
Time frame: Baseline to day 15
Anxiety status survey: Zung-SAS
Time frame: Baseline to day 15
Depression status survey: Zung-SDS
Time frame: Baseline to day 15
Sleep status survey: The Pittsburgh sleep quality index (PSQI)
Time frame: Baseline to day 15
Change of maternal weight from baseline to last visit
Time frame: Baseline to day 15
Change of electrolyte index (sodium)
Time frame: Baseline to day 15
Change of electrolyte index (potassium)
Time frame: Baseline to day 15
Change of electrolyte index (calcium)
Time frame: Baseline to day 15
Change of electrolyte index (chlorine)
Time frame: Baseline to day 15
Change of electrolyte index (phosphorus)
Time frame: Baseline to day 15
Change of electrolyte index (magnesium)
Time frame: Baseline to day 15
Change of electrolyte index (iron)
Time frame: Baseline to day 15
Change of electrolyte index (zinc)
Time frame: Baseline to day 15
Carbon dioxide combining power in the blood
Time frame: Baseline to day 15
Change of AST
Time frame: Baseline to day 15
Change of ALT
Time frame: Baseline to day 15
Change of ALP
Time frame: Baseline to day 15
Change of creatinine
Time frame: Baseline to day 15
Change of urea
Time frame: Baseline to day 15
Change of TSH
Time frame: Baseline to day 15
Change of free triiodothyronine
Time frame: Baseline to day 15
Change of free thyroxine
Time frame: Baseline to day 15
Change of cortisol
Time frame: Baseline to day 15
Change of ghrelin
Time frame: Baseline to day 15
Change of leptin
Time frame: Baseline to day 15
Change of 5-hydroxytryptamine
Time frame: Baseline to day 15
Change of substance P
Time frame: Baseline to day 15
Change of arginine vasopressin plasma
Time frame: Baseline to day 15
Change of GDF 15
Time frame: Baseline to day 15
Change of IGFBP 7
Time frame: Baseline to day 15
Number of participants with intravenous fluid treatment during treatment
Time frame: Baseline to day 15
Number of participants with concomitant treatment
Time frame: Baseline to day 15
Number of participants with hospital admission during treatment
Time frame: Baseline to day 15
Number of participants with termination of pregnancy
Time frame: Data collected from baseline to 1 week after termination of pregnancy
Pregnancy complications
Time frame: Data collected from baseline up to 42 days after parturition
Number of participants with preterm birth
Time frame: Data collected from baseline to 42 days after postpartum
Delivery outcomes
Time frame: Data collected from baseline to 42 days after postpartum
Number of participants with neonatal congenital anomalies
Time frame: Data collected from baseline to 42 days after postpartum.
Number of participants with neonatal mortality
Time frame: Data collected from baseline to 42 days after postpartum.
Number of participants with neonatal hypoglycemia
Time frame: From baseline to 42 days after postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dongmei Huang, Doctor principal investigator
Huazhong University of Science and Technology
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thumbtack needle in people with Nausea and Vomiting in Pregnancy (NVP), run by Dongmei Huang at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Huang, Doctor (86 13971578190 ext. 86 27 83663237, hdmjcr@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15. (time frame: Baseline to day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.